Use Instructions

1
1.0 THE OPTIMIZER SMART MINI SYSTEM
The OPTIMIZER Smart Mini system is comprised of the following components:
• OPTIMIZER Smart Mini Implantable Pulse Generator (IPG)
• Intelio Programmer
• Vesta Charger
The OPTIMIZER Smart Mini IPG is designed to be used with two commercially available ventricular
pacing leads but may also be used with an additional, optional atrial lead.
1.1 Description of the OPTIMIZER Smart Mini System
The OPTIMIZER Smart Mini Implantable Pulse Generator (IPG) is a Class III medical device
intended for the treatment of moderate to severe heart failure; a condition wherein the heart
muscle does not pump blood as well as it should, resulting in reduced cardiac output. The
OPTIMIZER Smart Mini IPG monitors the heart’s intrinsic activity and delivers Cardiac
Contractility Modulation (CCM) therapy to cardiac tissue during the ventricular absolute refractory
period, when the cardiac tissue is not capable of activation, thus rendering the CCM therapy as
non-excitatory. CCM therapy delivery is synchronized with the detected local electrical activity
and is designed to treat heart failure by increasing the cardiac output or increasing the
contractility of cardiac muscle.
The Intelio Programmer uses telemetry to interrogate and program the OPTIMIZER Smart Mini
IPG. With the Intelio Programmer, the physician can obtain diagnostic data from the OPTIMIZER
Smart Mini IPG as well as tailor the operating parameters of the OPTIMIZER Smart Mini IPG to
meet the specific requirements of each patient.
The Vesta Charger is powered by a rechargeable battery and is used by the patient to charge
their implanted OPTIMIZER Smart Mini IPG transcutaneously using inductive energy transfer. It
incorporates a graphical display which shows a different screen for each operational state as well
as alerts and other information it receives through daily communications with the OPTIMIZER
Smart Mini IPG.
1.2 OPTIMIZER Smart Mini IPG Implantable Leads Requirements
The OPTIMIZER Smart Mini IPG is connected to two (2) or three (3) implantable leads; two (2)
leads are implanted in the right ventricle and one (1) optional lead implanted in the right atrium.
The OPTIMIZER Smart Mini IPG is compatible with a standard pacemaker lead equipped with an
IS-1 connector.
The implanting physician may select any standard ventricular pacing leads with the following
characteristics:
• Bipolar lead approved for transvenous intracardiac ventricular pacing.
• Standard IS-1 BI (bipolar) connector.
• Maximum lead diameter 8 French
• Active fixation with an electrically-active corkscrew and distal electrode with an
electrically-active surface area of ≥ 3.6 mm
2
.
• Distal (tip) electrode coated with low-polarization coating (e.g., titanium nitride or iridium
oxide).
• Proximal (Ring) electrode electrically-active surface of at least 3.6 mm
2
, and Tip-Ring
spacing between 8 and 30 mm
• Maximum total wire resistance of 200 Ω
Note: The leads qualified for delivering CCM therapy from OPTIMIZER IPGs must be commercial
models that are FDA approved.